Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-29

Study Completion Date

2033-09-30

Brief Summary

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This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

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Detailed Description

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As part of the current clinical remediation work under the new Medical Device Regulation (MDR), limited data have been identified to support the hemiarthroplasty indication for some of Corin femoral stems. Therefore, this PMCF study has been implemented to collect safety and performance data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Conditions

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Hip Fractures Hip Hemiarthroplasty Osteoarthritis, Hip Avascular Necrosis of Hip Femoral Neck Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Hip hemiarthroplasty with BiPolar i and cemented stems (Meije or Oceane+)

Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices

Bipolar i and cemented stem (Océane+ or Meije)

Intervention Type DEVICE

Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Interventions

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Bipolar i and cemented stem (Océane+ or Meije)

Hip hemiarthroplasty is a surgical procedure that involves replacing half of the hip joint

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Both genders.
2. Adult subjects.
3. Subjects clinically suitable for a hip hemiarthroplasty surgery with Corin hip devices based on physical examination, medical history and diagnosis such as: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, revision of failed partial hip replacements in which the acetabulum does not require replacement.
4. The subject is willing to comply with the required follow-up visits as per protocol.
5. The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion Criteria

1. Subjects with active infection or sepsis or osteomyelitis.
2. Subjects with unsuitable or insufficient bone support preventing proper fixation of the prosthesis.
3. Subject with marked bone loss or bone absorption.
4. Subject with metabolic disorders which may impair bone formation or bone quality.
5. Subjects under guardianship.
6. Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No